Dear Senator Schumer

It has come to my attention that you are Chairman of the Joint Economic Committee, and as such, will be presiding over a meeting this Thursday, July 24th, regarding skyrocketing prices of certain prescription drugs and competitive market pricing. A good friend of mine, Mrs. Danielle Foltz, will be speaking at that meeting.

Mrs. Foltz and I are “virtual” friends, friends in the Internet world, through blogging and support groups. She lives in Rhode Island and I am in your home state of New York. Neither of us had crossed paths until our children were afflicted with the same rare devastating illness. Though I have never met Mrs. Foltz, or her son Trevor, our paths have joined. Both our sons are now survivors of Infantile Spasms, a devastating form of childhood epilepsy that can cause hundreds of seizures a day and severe developmental regression. Science has proven that the quicker the seizures are stopped, the better the chance a child can recover, both physically and developmentally.

But this meeting isn’t about childhood epilepsy; it is about skyrocketing prices of prescription drugs for rare diseases. When a child is first diagnosed with Infantile Spasms, the parents must come to terms with the devastating news. Then you are told there is no FDA indicated treatment, however, Acthar Gel, an injectable corticosteroid, is the best choice for quick seizure cessation. You are told of the likely, terrible side effects that could occur. Now, as a parent, watching your child suffer, you know that your life has changed forever. Your child is very sick and the “best” medicine that could help has terrible side effects. That alone is more than some parents can handle. But then, your insurance company denies this very medication, this liquid hope, because of cost concerns.

In early 2007, Questcor Pharmaceuticals submitted an sNDA to the FDA for indication of Infantile Spasms on Acthar Gel. The sNDA was denied. As a result, in August 2007, Questcor Pharmaceuticals, relying on the Orphan Drug Laws, implemented manufacturing changes and created a new business model. The Infantile Spasms community feels Questcor abused a law meant to foster research for new medications, not change manufacturing processes for old medications. By relying on this law, they raised the price of Acthar Gel from roughly $1500 a vial to over $23,000 a vial. The price is now over $36,000 a vial. Most children afflicted with Infantile Spasms will need 5 vials for one course of treatment. In today’s market, that is over $150,000 for one course that may or may not work.

If the child’s insurance company DOES approve the cost of Acthar Gel, these children will use a sizeable portion of their lifetime insurance cap on one treatment, a treatment with no guarantees. If the child’s health insurance company DOES NOT approve the cost of Acthar Gel, then parents are stuck determining if they canfind a way to pay out of pocket or use another, possibly less effective treatment.Of course a third option would be for a parent to quit their job and hope Medicaid will cover their child and the cost of this medication. How is a parent supposed to choose?Either way, the financial impact to the family can be overwhelming. Knowing that science has put you on a timeline, for the best developmental outcome, only makes the situation that much harder.

Trevor Foltz was lucky because his insurance company finally approved the cost of Acthar Gel.Todayhe is free of Infantile Spasms.

With my son Austin, we chose a different route. Relying on the FDA Compassionate Use Laws, we imported Vigabatrin, the first line medication for Infantile Spasms in Europe and Canada. Because the medication is not FDA approved (though it will be going before FDA committee on August 7th, 2008), we have to pay out of pocket for this medication. Vigabatrin is not in the price range of Acthar Gel, but as members of the middle class, we still are burdened by the cost. No matter, Vigabatrin stopped my son’s Infantile Spasms and he is now a kindergartner in the Niskayuna School District. He didn’t make it through unscathed, he still receives many forms of therapy, but we know the situation could have been much worse.

The situation for kids with Infantile Spasms is difficult, because there is no FDA indicated medication specifically for this form of Epilepsy. Many medications are used based off-label. I feel if the FDA approved medications like Acthar Gel and Vigabatrin for Infantile Spasms specifically, there would be market competition that would help keep costs lower. But, when you are the parent of a very sick child, you don’t want to have to think about things like cost and medication availability. You want to focus on your child and your family and healing.

The members of the Infantile Spasms community, though small in number, can’t help but feel our children and their plight is a very important one. As an advocate for lower priced drugs and a competitive pricing market, please help correct this situation. Don’t let another child continue to suffer.

4 Responses

Jen, Wonderfully written. I’m assuming that you actually sent this letter to him also. If so, I pray that he takes notice of this situation and brings it to the attention to all the other Senator’s.

Hell and I thought the $40 for Augmentin that Haylee needed was outrageous. I actually cursed at the pharmacist at Walmart about this. He told me “They don’t have a generic brand for this strength of Augmentin.” WTF???? How can you make a generic brand of something for one strength and not the other??? I have to find time to call the insurance company and/or the drug company to find out if this is true. That is the dumbest thing I have ever heard of. I know I look young, but I certainly wasn’t born yesterday!